Ibupas

PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPAS 136 mg medicated patch

Ibuprofen
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• This medicine is available without a prescription. However, you must use it carefully to achieve the best results.
• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 14 days of treatment.

Contents of this leaflet:

1. What IBUPAS is and what it is used for
2. Before you use IBUPAS
3. How to use IBUPAS
4. Possible side effects
5. How to store IBUPAS
6. Contents of the pack and other information

1. WHAT IBUPAS IS AND WHAT IT IS USED FOR

IBUPAS is a pharmaceutical formulation containing ibuprofen as the active substance, a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic properties, which is released via transdermal route.
IBUPAS is indicated for the local treatment of pain and inflammation of rheumatic or traumatic origin affecting joints, muscles, tendons, and ligaments.

2. BEFORE USING IBUPAS

Do not use IBUPAS

• If you are allergic to the active substance or to any of the excipients.
• On open wounds or lesions; use only on intact skin. Avoid contact with eyes and mucous membranes.
• If you have previously experienced an episode of hypersensitivity (asthma, allergic rhinitis, skin rashes, or anaphylactic reactions) or gastrointestinal bleeding due to anti-inflammatory drugs.
• If you currently have active peptic ulcer, bronchial asthma, or are undergoing anticoagulant therapy.
• During the third trimester of pregnancy and while breastfeeding.
• In children under 12 years of age.
• In case of severe heart failure.
• In case of severe renal or hepatic impairment.

Take special care with IBUPAS
Analgesics, antipyretics, and non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may cause hypersensitivity reactions, potentially severe, even in individuals not previously exposed to this type of medication.
IBUPAS should be used with great caution and only on medical advice:

• In elderly patients,
• In patients with chronic bronchitis, allergic rhinitis, or inflammation of the nasal mucosa (in whom asthmatic attacks or severe inflammatory skin and mucosal reactions are more frequent),
• In patients with a history of gastrointestinal disorders (such as gastrointestinal ulcers, ulcerative colitis, or Crohn’s disease),
• In patients with a history of gastrointestinal bleeding—even if not caused by NSAID administration—or other bleeding disorders,
• In patients with hepatic or renal dysfunction or heart failure,
• If you suffer or have suffered from high blood pressure.

Use of IBUPAS with other medicines, foods, or drinks
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicinal products, including those without a prescription.
It is unlikely that the use of ibuprofen-containing patches will lead to interactions with other medicines, foods, or drinks. However, concomitant topical or systemic use of other medications containing ibuprofen, other NSAIDs, corticosteroids, anticoagulants, or antiplatelet agents is not recommended.

Fertility, pregnancy, and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
IBUPAS is contraindicated during the third trimester of pregnancy and during breastfeeding, and is not recommended in women intending to become pregnant.
Based on experience with systemic NSAID therapy, the following is advised:

Pregnancy
Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonic/fetal development. Epidemiological studies suggest an increased risk of miscarriage, cardiac malformations, and gastroschisis following the use of prostaglandin synthesis inhibitors during early pregnancy. The absolute risk of cardiac malformations increases from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of treatment. In animal studies, administration of prostaglandin synthesis inhibitors has been shown to increase pre- and post-implantation loss and embryofetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular ones, has been reported in animals treated with prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimesters of pregnancy, ibuprofen should not be administered unless strictly necessary. If used in women attempting conception or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low and as short as possible, respectively.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligohydramnios; and may expose the mother and newborn, at the end of pregnancy, to:
• possible prolongation of bleeding time, an antiplatelet effect that may occur even at very low doses;
• inhibition of uterine contractions, resulting in delayed or prolonged labor. Therefore, ibuprofen is contraindicated during the third trimester of pregnancy.

Breastfeeding
Ibuprofen is excreted in breast milk: at therapeutic doses and during short-term treatment, the risk of effects on the newborn appears unlikely. However, in the case of long-term treatment, early weaning should be considered. NSAIDs should be avoided during breastfeeding.

Fertility
The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women experiencing difficulty conceiving or undergoing infertility investigations, ibuprofen treatment should be discontinued.

Driving and operating machinery
No specific studies are available. However, it is unlikely that IBUPAS has any effect on the ability to drive vehicles or operate machinery.

3. HOW TO USE IBUPAS

Apply IBUPAS exactly as instructed in this leaflet. If you have any doubts, consult your doctor or pharmacist.
Instructions for use
Warning: Do not exceed the recommended doses without medical advice.
Use one medicated patch at a time and replace it every 24 hours for no longer than 14 days.
Do not apply two patches within the same day.
IBUPAS is intended for use on intact skin only.
It is recommended to wash and thoroughly dry the painful area before applying the medicated patch.
If the medicated patch needs to be applied to joints subject to extensive movement, such as the elbow or knee, it is advisable to apply it longitudinally rather than transversely, taking care to attach the patch while the joint is partially flexed. To apply the patch, partially peel off the two sections of transparent protective film from the central area of the medicated patch so that an adhesive surface of 2–3 cm is exposed. Apply this area to the skin at the center of the painful site. Slowly peel off each protective film one after the other, taking care to avoid folds or the patch sticking to itself.
Immediately after applying the medicated patch, gently massage the skin for approximately 20 seconds to ensure proper adhesion of the patch.
If you use more IBUPAS than you should
Due to the characteristics of this pharmaceutical form, overdose effects are unlikely.
If you have used more IBUPAS than recommended or if your child has accidentally used this medicine, always contact a doctor or the nearest hospital for advice on potential risks and the necessary actions to take.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, feeling cold, and breathing difficulties have been reported.
If you forget to use IBUPAS
Apply the missed patch as soon as you remember.
However, if it is almost time for the next scheduled patch, apply only the next one as regularly planned.
Do not apply two patches within the same day.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF IBUPAS, CONSULT YOUR DOCTOR OR
PHARMACIST.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, IBUPAS can cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined according to the following convention:
Very common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1,000 to <1/100; Rare: ≥1/10,000 to <1/1,000; Very rare: <1/10,000; Not known (cannot be estimated from the available data).

The following adverse reactions have been observed in controlled clinical studies with this product:

Nervous system disorders
Common: Dry mouth, headache, taste disturbances

Gastrointestinal disorders
Common: Nausea

Skin and subcutaneous tissue disorders
Common: Facial swelling, blisters

Musculoskeletal and connective tissue disorders
Common: General malaise

General disorders and administration site conditions
Very common: Mild skin redness or slight irritation at the application site, which rapidly resolves after removal of the medicated patch.
Common: Itching, burning, evident skin irritations with redness, skin peeling, and minor skin lesions.

All adverse reactions observed in clinical studies were mild and transient in nature.

In literature data, the following adverse reactions have been reported:

Immune system disorders
Not known: Local hypersensitivity reactions

General disorders and administration site conditions
Not known: Contact dermatitis, numbness and tingling at the application site

With this type of medicinal product, rare cases of severe and widespread dermatological lesions have also been reported, such as erythema multiforme, Quincke's edema, and, very rarely, bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

A severe skin reaction known as DRESS syndrome may also occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cells).

Photosensitivity reactions are possible.

Systemic adverse reactions following topical use of ibuprofen are unlikely, as plasma levels of ibuprofen detected after application of IBUPAS are much lower than those observed with systemic administration of ibuprofen-containing medicines. However, with prolonged use beyond the recommended duration, or failure to observe contraindications and warnings, the occurrence of systemic adverse reactions, particularly gastrointestinal effects, cannot be ruled out.

Following the instructions provided in this leaflet reduces the risk of adverse reactions.

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, please consult your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE IBUPAS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Once the package has been opened, the patches must be used within 3 months.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the information available; therefore, retain both the carton
and the package leaflet.

6. Package contents and other information

What IBUPAS contains:
One medicated patch contains:
Active substance:
Ibuprofen 136 mg
The other components are:
Potassium salt of the copolymer of 2-ethylhexyl acrylate, methyl acrylate, acrylic acid, glycidyl methacrylate,
oleic acid, Al.
Support matrix: PET
Protective film: Silicone-coated PET

Description of the appearance of IBUPAS and contents of the pack
IBUPAS is a medicated patch.
Box containing a resealable laminated pouch: the resealable pouch contains 5 or 7 medicated patches.

Marketing Authorization Holder
Alfasigma S.p.A. - Viale Sarca, n. 223 - 20126 Milan (MI)

Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)

This summary of product characteristics was last approved on: